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FDA approves Dr. Reddy’s Tosymra

Dr. Reddy’s Laboratories Ltd. and its subsidiary, Promius Pharma LLC, announced the approval of Tosymra (previously known as DFN-02) by the U.S. Food and Drug Administration.

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Seven Trends That Shaped 2018

Barring a last-minute reversal, 2018 will likely end as a down year for the biotech industry, at least in terms of stock performance.

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Novartis’ blood disorder drug gets FDA approval for expanded use

The U.S. Food and Drug Administration expanded the use of Novartis AG’s low platelets drug Promacta to treat patients with a rare, genetic blood disorder.

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FDA Approves Another Indication for Merck’s Keytruda

Merck’s blockbuster anti-PD-1 therapy Keytruda won FDA approval in combination with chemotherapy as a first-line treatment for patients with metastatic squamous non-small cell lung cancer.

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FDA Approves Genentech’s Xolair Prefilled Syringe Formulation

The FDA approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes for Genentech’s Xolair as an additional formulation for allergic asthma and chronic idiopathic urticaria.

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FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA), a Rare Form of Juvenile Arthritis

Roche Group member Genentech announced today that the U.S. FDA approved the subcutaneous formulation of Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.

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Novartis gains U.S. approval for delayed MS drug

Novartis’ Sandoz division won U.S. approval for a larger dosage of its Glatopa drug for multiple sclerosis patients, ending a costly delay that allowed rival generics makers to beat it to market.

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Ferring’s Zomacton Receives FDA Approval to Treat Growth Hormone Deficiency in Adults

Ferring Pharmaceuticals Inc. announced that the U.S. FDA approved Zomacton (somatropin) for Injection 5 mg and 10 mg recombinant human growth hormone (GH) indicated for replacement of GH in adults with GH deficiency.

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FDA approves drug for digestive tract cancer

The U.S. Food and Drug Administration approved French drugmaker Advanced Accelerator Application SA’s drug to treat patients with a type of digestive tract cancer.

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$11 billion biotech binge fuels forecasts of 2018 M&A surge

An $11 billion (8.12 billion pounds) burst of biotech bids in just four days has fueled expectations of a 2018 surge in life science deals as large drugmakers shop for promising assets from smaller rivals.

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